Quality Documentation Control Specialist in Plymouth, Minnesota at PROMED MOLDED PRODUCTS INC

POSITION SUMMARY

The Quality Assurance Document Control Specialist is responsible for day-to-day administration, maintenance, and continuous improvement of the organization’s document control within the Quality Management System (QMS) in a regulated pharmaceutical and medical device environment. Ensuring that QMS components are accurate, current, revised, approved, accessible and archived in a compliant manner. The Quality Documentation Control Specialist ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following:

• Administer the operations of the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, work instructions, forms, specifications, and quality records);
• Maintain document master lists and revision histories to ensure all controlled documents reflect the current approved version;
• Manage physical and/or hybrid document distribution, including retrieval and destruction of obsolete documents from points of use;
• Process document change requests, track change history, and support change impact assessments in collaboration with subject matter experts (SMEs);
• Assign and maintain document numbering schemes, version control conventions, and document retention schedules consistent with site SOPs and regulatory requirements;
• Ensure document templates are standardized, current, and compliant with applicable regulatory and quality standards;
• Oversee the creation, review, approval and distribution of controlled documents, including SOPs, policies, forms and work instructions with ALCOA principles;
• Maintains the documentation files in compliance with ISO 13485. FDA 21 CFR 820
• and 21 CFR Part 11;
• Manage electronic and physical document repositories;
• Support the periodic review process for controlled documents, notifying document owners of upcoming review dates and coordinating timely completion;
• Coordinate training assignments for new and revised documents, ensuring training records are completed and filed in a timely manner as applicable;
• Inputs data to create and revise material and method masters in the ERP system.

OTHER RESPONSIBILITIES

QUALIFICATION, EDUCATION & EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

Preferred:

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job:

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job: